Location
Gurgaon | India
Job description
VP, Safety & Pharmacovigilance
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Job responsibilities
• Accountable and develops performance strategy and business planning with Business Unit Head;
• Develops the vision for optimization of department under their remit by implementing strategic plans for the expansion of department revenue, operational margins, and resources;
• Leads and provides direction of performance improvement and operational excellence by identifying best practices and ideas for innovation and continuous improvement within Safety & PV;
• Collaborates with the leadership team to ensure cross-BU consistency by sharing lessons learned, building relationships with stakeholders and brokering relationships at all levels;
• Ensures that all aspects of the Company’s Safety & PV services are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements.
• Plans for the efficient allocation of resources within operations through resource management and review of utilization;
• Develop Change Management programmes, including adjustments based on emerging business or technical opportunities and challenges.
• Develop & socialize contingency plans and risk mitigation strategies to ensure success of Safety & PV;
• Responsible for line management including salary management, employment hires, transfers, terminations; performance management and professional development; job description preparation;
• Participates in Business Unit and department level financial reviews;
• Leads and drives analytics and reporting, systems compliance, and operational quality;
• Creates pathways for internal teams to maintain current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded Company services to all appropriate clients.
• Promote the application of best practices disciplines and approaches within a fast-paced, high tech environment;
• May serve as interface between Company, sponsors, vendors, and other departments in the area of Clinical Safety, Pharmacovigilance, Post Marketing and FSP services.
• Represents Safety & PV on Governance Committees, as required.
• Participates in corporate initiatives and/or represent Safety & PV in regional or business activities;
• Represents the Company at professional meetings and/or seminars.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
Qualifications
What we’re looking for
• PhD or MD degree. Minimum 15 years’ experience working in a Safety and/or Pharmacovigilance or clinical trial environment with a minimum of 9 years’ management experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to do the job.
• Extensive Safety and Pharmacovigilance or clinical research experience. Significant experience managing teams of diversely skilled professionals. Strong knowledge of clinical research and post-approval management processes. Understanding of the needs of countries and the ability to work across geographic regions. Strong CRO operational experience with project management experience working in an international/ global capacity. Thorough knowledge of applicable regulations and drug development procedures.
• Excellent leadership skills; ability to teach/mentor team members. Leads a team of employees to reach performance objectives. Strong ability to analyze data and make appropriate decisions. Excellent oral and written communication skills and strong presentation skills. Ability to motivate employees to define and reach team objectives. Ability to make difficult decisions under pressure and sometimes without all the information desired. High degree of flexibility. Takes initiative; is a self-starter. Oversight of all departmental activities. Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic and matrix environment.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Job tags
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